Study on the Application of Established Korean Medical Classics in the Korean Pharmaceutical Affairs Act

Seok-ki Eom; Eom, Seok-ki

doi:10.13048/jkm.14037

JKM > Volume 35(3); 2014 > Article

Eom: Study on the Application of Established Korean Medical Classics in the Korean Pharmaceutical Affairs Act

Original Article

Journal of Korean Medicine 2014; 35(3): 135-154.

Published online: September 30, 2014

DOI: https://doi.org/10.13048/jkm.14037

Study on the Application of Established Korean Medical Classics in the Korean Pharmaceutical Affairs Act

Seok-ki Eom¹^{, 2}

¹Dept. of Medical Consilience, Graduate School of Dan-Kook University

²Nexia Nano Cancer Institute, Dan-Kook University

Correspondence to: 엄석기 (Seok-ki Eom), 단국대학교 대학원, 단국넥시아나노암연구소, Tel: +82-31-260-5737, Fax: +82-31-260-5739, E-mail: sku0808@hanmail.net

Received August 18, 2014 Revised September 17, 2014 Accepted September 17, 2014

Abstract

Purpose:

There is an issue in applying various principles introduced in established Korean medical classics to “Pharmaceuticals Approval, Notification and Review” of “herbal medicinal preparations” and “new drugs from natural products” that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential.

Methods:

We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects.

Results:

Established Korean medical classics are applied as follows:

as criteria for Korean medicine distributors’ sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953),
as official compendiums for pharmacists’ preparation of Korean medicine (Ministry of Health and Welfare’s authoritative interpretation; from early 1970s to 1993),
as standards for oriental pharmacists’ quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995),
as criteria for “Pharmaceuticals Approval, Notification and Review” of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and
as standards for the quality of materials of health functional food (from 2004 to 2011).

Conclusion:

The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

Keywords: Established Korean medical classics, herbal medicinal preparations, crude drug preparations, Korean Pharmaceutical Affairs Act

Fig. 1.

The Application of Established Korean Medical Classics in Korean Pharmaceutical Affairs Act

Table 1.

The Changes of Provisional Regulations on Established Korean Medicinal Classics

년도	명칭	예규·고시 번호	비고
1969 년	기성 한약서에 대한 잠정 규정	보건사회부예규 233호	한약종상, 11종 한약서
2002년	기성 한약서에 대한 잠정 규정	보건복지부고시 제2002-79호	한약업사, 11종 한약서
2008년	기존 한약서에 대한 잠정 규정	보건복지가족부고시 제2008-175호	한약업사, 10종 한약서
2014년	기존 한약서에 대한 잠정 규정	보건복지부고시 제2014-27호	한약업사, 10종 한약서 제5조(재검토기한) 신설

Table 2.

The Comparison of Categories of Established Korean Medicinal Classics

1969년 6월 7일	1999년 2월 11일	2008년 8월 14일	2008년 12월 31일	2011년 5월 30일
<기성한약서에 대한 잠정규정>	<의약품 등의 안전성 유효성 심사에 관한 규정>	<의약품 등의 품목허가신고심사 규정>	<기존한약서에 대한 잠정규정>	<한약(생약)제제 등의 품목허가신고에 관한 규정>
기성한약서	한약서	한약서	기존한약서	한약서
	한약조제지침서
동의보감	동의보감	동의보감	동의보감	동의보감
방약합편	방약합편	방약합편	방약합편	방약합편
향약집성방	향약집성방	향약집성방	향약집성방	향약집성방
경악전서	경악전서	경악전서	경악전서	경악전서
의학입문	의학입문	의학입문	의학입문	의학입문
제중신편	제중신편	제중신편	제중신편	제중신편
광제비급	광제비급	광제비급	광제비급	광제비급
수세보원			수세보원
	동의수세보원	동의수세보원	동의수세보원	동의수세보원
본초강목	본초강목	본초강목	본초강목	본초강목
약성가	약성가	약성가
사상의학	사상의학
		한약조제지침서		한약조제지침서

Table 3.

Books for National Examination for Medical Practitioners in Joseon Dynasty and Established Korean Medicinal Classics

1486 성종16년	1749 영조24년	1865 고종15년	1969년 대한민국	2008년대한민국	2014년 대한민국
경국대전	속대전	대전회통	보건사회부예규제233호	보건복지가족부고시 제2008-175호	보건복지부고시제2014-27호
구급방
태산입요
창진집
본초	본초	본초
화제방
부인대전
득효방
직지방	직지방	직지방
동인경	동인경	동인경
찬도맥	찬도맥	찬도맥
	동원10서	동원10서
	의학정전	의학정전
	소문	소문
		의학입문	의학입문	의학입문	의학입문
			방약합편	방약합편	방약합편
			동의보감	동의보감	동의보감
			향약집성방	향약집성방	향약집성방
			광제비급	광제비급	광제비급
			제중신편	제중신편	제중신편
			약성가
			사상의학	동의수세보원	동의수세보원
			경악전서	경악전서	경악전서
			수세보원	수세보원	수세보원
			본초강목	본초강목	본초강목

Table 4.

Periodical Changes of the Function of Pharmacists and Distributors of Korean Medicine

조선	대한제국	일제강점기	건국이후	현재
主簿	藥劑士	藥劑士	약사(1953)	약사
主簿	藥劑士	藥劑士	한약사(1994)	한약사
藥商	藥種商(韓藥, 洋藥)	藥種商(서양약)	약종상(1953)	약종상
藥商	藥種商(韓藥, 洋藥)	漢藥種商(한약)	한약종상(1953) → 藥業士(1971) → 韓藥業士(1986)	한약업사

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